# Federal Register 2026-16727 — effective 2026-09-16 — Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product — Food and Drug Administration

For Federal Register 2026-16727, effective date is 2026-09-16; agency is Food and Drug Administration; published is 2026-08-17; cfr parts amended is 21 CFR 864, recorded from its source on 2026-08-31; source re-checked 2026-09-16.

- **FR document number:** 2026-16727 _(verified: appears in the quote below)_
- **Rule:** Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product _(verified: appears in the quote below)_
- **Agency:** Food and Drug Administration _(verified: appears in the quote below)_
- **Effective date:** 2026-09-16 _(verified: appears in the quote below)_
- **DATES, as printed:** This order is effective September 16, 2026. See further discussion in section IV, "Implementation Strategy."
- **CFR parts amended:** 21 CFR 864 _(our reading, not quoted from the source)_
- **Published:** 2026-08-17 _(verified: appears in the quote below)_

## What the source says

> {"document_number":"2026-16727","title":"Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product","agency_names":["Health and Human Services Department","Food and Drug Administration"],"effective_on":"2026-09-16","dates":"This order is effective September 16, 2026. See further discussion in section IV, \"Implementation Strategy.\"","cfr_references":[{"chapter":null,"citation_url":null,"part":"864","title":21}],"publication_date":"2026-08-17","html_url":"https://www.federalregister.gov/documents/2026/08/17/2026-16727/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with"}

## Source

- https://www.federalregister.gov/api/v1/documents.json?per_page=1000&order=oldest&conditions%5Btype%5D%5B%5D=RULE&conditions%5Beffective_date%5D%5Bgte%5D=2026-08-31&conditions%5Beffective_date%5D%5Blte%5D=2026-12-31&fields%5B%5D=document_number&fields%5B%5D=title&fields%5B%5D=agency_names&fields%5B%5D=effective_on&fields%5B%5D=dates&fields%5B%5D=cfr_references&fields%5B%5D=publication_date&fields%5B%5D=html_url

Last verified: 2026-09-16. Review by: 2026-09-29.
Part of [Federal rules taking effect: every US final rule in the Federal Register, by effective date](https://referencesource.org/federal-rules-taking-effect/).